Biopsy marker with anchoring capabilities

ABSTRACT

A biopsy marker having a spring-loaded anchor. The biopsy marker includes an insertion orientation and an anchored orientation. In the insertion orientation, the biopsy marker is manipulated under force to reduce the lateral span/cross-sectional area of the marker. In the anchored orientation, the biopsy marker is released and free to actively spring into a configuration in which the lateral span/cross-sectional area is greater than the lateral span/cross-sectional area of the biopsy marker when in the insertion orientation. In an embodiment, the spring-loaded anchor is configured to spring about a predefined rotational axis. An embodiment of the biopsy marker may be comprised of a single wire construction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This nonprovisional application is a continuation of and claims priorityto nonprovisional application Ser. No. 16/877,720, entitled “BIOPSYMARKER WITH ANCHORING CAPABILITIES,” filed May 19, 2020 by the sameinventor(s), which claims priority to provisional application No.62/963,707, entitled “BIOPSY MARKER WITH ANCHORING CAPABILITIES,” filedJan. 21, 2020 by the same inventor(s).

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates, generally, to biopsy markers. More specifically,it relates to a biopsy marker having spring-loaded anchoringcapabilities.

2. Brief Description of the Prior Art

Biopsy markers are used as a means to identify the location of tissue atsome later date. Typically, markers are placed in or near the relevanttissue following a biopsy procedure. The marker can then be identifiedat a later date using imaging equipment, such as an X-Ray machine.

Often, metallic biopsy markers are used alone or in combination withbioabsorbable markers. The metallic markers are not absorbed by the bodyand can be easily found using imaging equipment. However, metallicmarkers are susceptible to migration within the tissue. If the markermigrates from its intended position, the marker will no longer identifythe biopsy site. The marker effectively becomes useless.

Accordingly, what is needed is a simple, easy to manufacture, and easyto use biopsy marker having an active anchoring means to ensure that thebiopsy marker does not migrate from the biopsy site. However, in view ofthe art considered as a whole at the time the present invention wasmade, it was not obvious to those of ordinary skill in the field of thisinvention how the shortcomings of the prior art could be overcome.

All referenced publications are incorporated herein by reference intheir entirety. Furthermore, where a definition or use of a term in areference, which is incorporated by reference herein, is inconsistent orcontrary to the definition of that term provided herein, the definitionof that term provided herein applies and the definition of that term inthe reference does not apply.

While certain aspects of conventional technologies have been discussedto facilitate disclosure of the invention, Applicant in no way disclaimsthese technical aspects, and it is contemplated that the claimedinvention may encompass one or more of the conventional technicalaspects discussed herein.

The present invention may address one or more of the problems anddeficiencies of the prior art discussed above. However, it iscontemplated that the invention may prove useful in addressing otherproblems and deficiencies in a number of technical areas. Therefore, theclaimed invention should not necessarily be construed as limited toaddressing any of the particular problems or deficiencies discussedherein.

In this specification, where a document, act or item of knowledge isreferred to or discussed, this reference or discussion is not anadmission that the document, act or item of knowledge or any combinationthereof was at the priority date, publicly available, known to thepublic, part of common general knowledge, or otherwise constitutes priorart under the applicable statutory provisions; or is known to berelevant to an attempt to solve any problem with which thisspecification is concerned.

BRIEF SUMMARY OF THE INVENTION

The long-standing but heretofore unfulfilled need for a simple, easy tomanufacture, and easy to use biopsy marker having an active anchoringmeans to ensure that the biopsy marker does not migrate from the biopsysite is now met by a new, useful, and nonobvious invention.

An embodiment of the present invention includes a biopsy marker having abioabsorbable component and a non-bioabsorbable component. Thenon-bioabsorbable component includes a body section having a predefinednon-linear shape. In an embodiment the body section resides at leastpartially within the bioabsorbable component. The non-absorbablecomponent further includes a spring component residing between ananchoring arm and the body section.

The biopsy marker includes an insertion orientation and an anchoringorientation. The insertion orientation includes the biopsy marker havinga cross-sectional area that is less than the cross-sectional area of thebiopsy marker when in the anchoring orientation. The insertionorientation further includes the anchoring arm being subject to anexternal force to overcome a spring force from the spring component. Theanchoring orientation includes the anchoring arm being free of theexternal force and the spring component causes the anchoring arm tospring outward to increase the cross-sectional area of the biopsymarker.

An embodiment includes a non-linear scaffolding section at a distal endof the anchoring arm. In an embodiment the scaffolding includes a j-hookor a barb-like feature to better anchor to a patient's tissue.

In some embodiments, the body section has a coil-shape. In someembodiments, the spring component is a torsion spring. In otherembodiments, the spring component is an elbow spring.

In some embodiments, the non-bioabsorbable component is made from ametallic material. In some embodiments, the non-bioabsorbable componentis made from a single continuous wire. In some embodiments thebioabsorbable component is comprised of an expandable material that canbe dehydrated to reduce its size and hydrated to increase its size.

Some embodiments include the body section residing within thebioabsorbable component when the bioabsorbable component is in adehydrated state. In addition, a beam extends between the body sectionand the spring component. The beam has a length greater than a distancebetween the body section and an outer surface of the bioabsorbablecomponent when in the dehydrated state, such that the spring componentresides outside of the bioabsorbable component when in the dehydratedstate.

Some embodiments include a second spring component residing between asecond anchoring arm and the body section. The insertion orientationfurther includes the second anchoring arm being subject to an externalforce to overcome the spring force from the second spring component andthe anchoring orientation further includes the second anchoring armbeing free of the external force and the second spring component causingthe second anchoring arm to spring outward to increase thecross-sectional area of the biopsy marker.

Some embodiments of the present invention include a non-bioabsorbablecomponent of a biopsy marker created from a single wire. In anembodiment, the single wire has a circular cross-sectional shape. Someembodiments include the single wire having a non-circularcross-sectional shape which can impact the direction and amount ofspring force. In some embodiments, the non-bioabsorbable component has acoil-shaped body section. A beam extends from the body section to aspring component residing between an anchoring arm and the body section.

The non-bioabsorbable component has an insertion configuration and ananchoring configuration. The non-bioabsorbable component has a smallercross-section in the insertion configuration than when in the anchoringconfiguration. In other words, the non-bioabsorbable component, whenviewed from an end view (i.e., in line with the longitudinal axis), hasa greater outwardly span, relative to the longitudinal axis of thebiopsy mark, when in an anchoring orientation than when in an insertionorientation. The insertion configuration includes the anchoring armbeing subject to an external force to overcome a spring force from thespring component and the anchoring configuration includes the anchoringarm being free of the external force and the spring component causes theanchoring arm to spring outward to increase the cross-sectionalarea/span of the biopsy marker in a lateral/radial direction.

In an embodiment, the non-bioabsorbable component includes a second beamextending from the body section to a second spring component that isconnected to a second anchoring arm. The insertion orientation furtherincludes the second anchoring arm being subject to the external force toovercome the spring force from the second spring component. Theanchoring orientation further includes the second anchoring arm beingfree of the external force and the second spring component causes thesecond anchoring arm to spring outward to increase the cross-sectionalarea/span of the non-bioabsorbable component.

These and other important objects, advantages, and features of theinvention will become clear as this disclosure proceeds.

The invention accordingly comprises the features of construction,combination of elements, and arrangement of parts that will beexemplified in the disclosure set forth hereinafter and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the invention, reference should be made tothe following detailed description, taken in connection with theaccompanying drawings, in which:

FIG. 1A is a front view of an embodiment of the present invention.

FIG. 1B is a top view of an embodiment of the present invention.

FIG. 1C is a side view of an embodiment of the present invention.

FIG. 2A is an embodiment of the present invention in the insertionconfiguration within a delivery device.

FIG. 2B is an embodiment of the present invention leaving the distal endof a delivery device.

FIG. 3A is a front view of an embodiment of the non-absorbablecomponent.

FIG. 3B is a top view of an embodiment of the non-absorbable component.

FIG. 3C is a side view of an embodiment of the non-absorbable component.

FIG. 4A is a front view of an embodiment of the present invention.

FIG. 4B is a top view of an embodiment of the present invention.

FIG. 4C is a close-up view of detail C from FIG. 4A.

FIG. 4D is a side view of an embodiment of the present invention.

FIG. 5 is a front view of an embodiment of the present invention.

FIG. 6A is a front view of an embodiment of the non-absorbablecomponent.

FIG. 6B is a top view of an embodiment of the non-absorbable component.

FIG. 6C is a side view of an embodiment of the non-absorbable component.

FIG. 6D is a front view of FIG. 6A with the bioabsorbable componentshown in both a dehydrated and hydrated stage.

FIG. 6E is a top view of FIG. 6B with the bioabsorbable component shownin both a dehydrated and hydrated stage.

FIG. 6F is a side view of FIG. 6C with the bioabsorbable component shownin both a dehydrated and hydrated stage.

FIG. 7A is a front view of an embodiment of the non-absorbablecomponent.

FIG. 7B is a top view of an embodiment of the non-absorbable component.

FIG. 7C is a side view of an embodiment of the non-absorbable component.

FIG. 7D is a front view of FIG. 7A with the bioabsorbable componentshown in both a dehydrated and hydrated stage.

FIG. 7E is a top view of FIG. 7B with the bioabsorbable component shownin both a dehydrated and hydrated stage.

FIG. 7F is a side view of FIG. 7C with the bioabsorbable component shownin both a dehydrated and hydrated stage.

FIG. 8 is a front view of an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description of the preferred embodiments,reference is made to the accompanying drawings, which form a partthereof, and within which are shown by way of illustration specificembodiments by which the invention may be practiced. It is to beunderstood that other embodiments may be utilized, and structuralchanges may be made without departing from the scope of the invention.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the context clearly dictates otherwise.

As used herein, “substantially perpendicular” will mean that two objectsor axis are exactly or almost perpendicular, i.e. at least within fivedegrees or ten degrees of perpendicular, or more preferably within lessthan one degree of perpendicular. Similarly, the term “substantiallyparallel” will mean that two objects or axis are exactly or almostparallel, i.e. are at least within five or ten degrees of parallel andare preferably within less than one degree of parallel.

As used herein, the term “subject,” “patient,” or “organism” includeshumans and animals (e.g., mice, rats, pigs, cats, dogs, and horses).

As depicted in FIG. 1 , an embodiment of the present invention includesa biopsy marker comprised of bioabsorbable/biodegradable component 101and non-absorbable component 103. In some embodiments at least a portionof non-absorbable component 103 resides within bioabsorbable component101. In some embodiments, as will be explained herein, at least bodysection 102 of non-absorbable component 103 resides within bioabsorbablecomponent 101 and is non-linear and/or multi-dimensional to preventnon-absorbable component 103 from sliding out of bioabsorbable component101.

In some embodiment, bioabsorbable component 101 is comprised of anexpandable material, such as hydrogel, that will expand upon contactwith a patient's internal tissue or biological fluids. In someembodiments, bioabsorbable component 101 is comprised of anybioabsorbable material, including but not limited to polyglycolic acid(PGA), polylactic acid (PLA), sugar-based compositions, starch-basedcompositions, or biological-based composition such as collagen,hydrogel, or any combination of the aforementioned. In some embodiments,bioabsorbable component 101 is a bio-plug designed to close an openingor hole somewhere within a patient's body. The bioabsorbable componentmay be any size and can be generally any shape. In an embodiment,bioabsorbable component 101 is cylindrical in shape and has a dehydratedcross-sectional size generally equal to the cross-sectional area of aninternal lumen of delivery device 202 as shown in FIG. 2 .

In some embodiments, at least a portion of non-absorbable component 103is comprised of one or more metallic materials, including but notlimited to nitinol, titanium, and stainless steel. Non-absorbablecomponent 103 will remain within a patient long after bioabsorbablecomponent 101 is absorbed or broken down. Non-absorbable component 103helps to easily identify biopsy marker 100 using imaging equipment,including but not limited to, X-ray machines, CT scanners, ultrasoundmachines, or MRI machines. Some embodiments include at least bodysection 102 of non-absorbable component 103 comprised of a material thatis identifiable through at least one imaging machine.

As depicted in FIGS. 1-3 , an embodiment of the present inventionincludes body section 102 of non-bioabsorbable component 103 residingwithin bioabsorbable component 101. Body section 102 has a uniquelyidentifiable shape that (1) provides a means of ensuring thatnon-bioabsorbable component 103 cannot be easily removed frombioabsorbable component 101 comprised of soft material like hydrogel and(2) helps to easily identify biopsy marker 100 using imaging equipment.

In some embodiments, body section 102 is designed to have a size andshape that cannot pass through the tunnel/canals in bioabsorbablecomponent 101 in which beams 104 reside without rupturing at least oneof the canals. In some embodiments, body section 102 is designed to havea size and shape that is larger in cross-section than the canals inbioabsorbable component 101 in which beams 104 reside. Beams 104 providethe structural connection between body section 102 and the anchoringcomponents. If body section 102 is the same size and shape as beam(s)104, body section 102 could more easily exit bioabsorbable component 101and potentially cause the two components to become separated from eachother prior to the absorption of bioabsorbable component 101. For thesame reason, body section 102 as a whole has a size and shape that islarger in cross-section than beam(s) 104. In some embodiments, for thesame reason, body section 102 has a shape that is not linear.

The exemplary depicted shape of body section 102 is in the form of acoil. The depicted coil in FIGS. 1-4 includes three interconnected,concentric circles; however, some embodiments have a coil comprised oftwo interconnected concentric circles (see FIGS. 5-6 ) to reduce thesize of the marker and ultimately the size of the delivery device. Anembodiment has body section 102 comprised of a single concentric circleor a body section 102 comprised of a U-shape extending between first andsecond beams 104 a, 104 b to further reduce the size of biopsy marker100 and allow a surgeon to insert the marker using a smaller deliverdevice. In some embodiments, body section 102 may be any non-linearshape, including but not limited to a horseshoe, a sinusoidal wave, andan M.

As depicted in FIGS. 1-3 , body section 102 has central longitudinalaxis 114 that is perpendicularly oriented with respect to centrallongitudinal axis 112 of biopsy marker 100 as a whole. As depicted inFIG. 4 , some embodiments, include coil-shaped body section 102 orientedso that central axis 114 of the coil is coaxial with centrallongitudinal axis 112 of biopsy marker 100. Some embodiments includecentral coil axis 114 at an angle between 0 and 90 degrees with respectto longitudinal axis 112 of biopsy marker 100.

In some embodiments, the integrated concentric circles of which the coilis comprised are tightly arranged to minimize the size of body section102. The spacing between the integrated concentric circles, however, maybe adjusted depending on the desired size of body section 102 and thedesired amount of resistance to movement within bioabsorbable component101 as created through variations in the spacing of the integratedconcentric circles. The size of the circles of which the coil iscomprised can also be adjusted depending on the desired size of bodysection 102 and the desired amount of resistance to movement withinbioabsorbable component 101 as created through variations in the size ofthe integrated concentric circles.

The size of body section 102 can also be adjusted as needed to fit aspecific delivery device 202. Depending on the area of insertion withina patient's body, the cross-sectional area of the internal lumen ofdelivery device 202 can vary. Ultimately, the cross-sectional size ofbody section 102 (with respect to longitudinal axis 112 of biopsy marker100) will be equal to or less than the cross-sectional area of theinternal lumen of delivery device 202. In an embodiment, the size ofbody section 102, extending in a direction parallel to longitudinal axis112 of biopsy marker 100, will be equal to or less than the length ofbioabsorbable component 101 extending in a direction parallel tolongitudinal axis 112 of biopsy marker 100. Likewise, an embodimentincludes the size of body section 102 extending outwardly in a lateraldirection (i.e. perpendicular with respect to longitudinal axis 112)being less than or equal to the size of bioabsorbable component 101 inthe same direction.

In some embodiments, body section 102 has a shape that is not a coilshape. In some embodiments, the shape of body section 102 is one thatenables the entire non-absorbable component 103 to be comprised of asingle continuous wire. In some embodiments, the shape of body section102 is one that enables body section 102, beams 104, spring 106, andanchoring arms 108 to be comprised of a single wire. In someembodiments, the shape of body section 102 is one that enables bodysection 102, beams 104, and spring 106 to be comprised of a single wire.In some embodiments, the shape of body section 102 is one that enablesbody section 102 and beams 104 to be comprised of a single wire. In someembodiments, the shape of body section 102 is one that can be comprisedof a single wire.

Some embodiments of the present invention include multiple biopsymarkers with each having a visibly distinct variation in the shape ofbody sections 102. The variation in shapes of body sections 102 betweendifferent biopsy markers allows multiple biopsy markers to be insertedinto a patient with each remaining visibly distinct when viewed throughimaging equipment. For example, the coil shape, number of coils,orientation of the coil, size of the coil, size of the concentriccircles of the coil, or spacing between circles within a coil can beadjusted to ensure that various biopsy markers can be differentiatedfrom each other using imaging equipment. Likewise, different shapes ofbody section 102 between various biopsy markers can be used. Forexample, different biopsy markers may have a body section 102 shaped asa coil, a horseshoe, a sinusoidal wave, an M, etc. Preferably the shapesare those which can be created by manipulating or bending a single wire.

Biopsy marker 100 of the present invention further includes at least onebeam 104 extending away from body section 102 towards spring 106. Theone or more beams 104 provide the mechanical interconnection betweenbody section 102 and springs 106. In some embodiments, beam(s) 104extend in a direction generally parallel to longitudinal axis 112 ofbiopsy marker 100. Extending in this direction helps to limit thecross-sectional area of biopsy marker 100. Some embodiments includebeams 104 extending from body section 102 in a direction that is notgenerally parallel with longitudinal axis 112.

As depicted in FIGS. 1-4 , some embodiments include two beams 104 a, 104b. In FIGS. 1-3 , both beams 104 a, 104 b extend in generally the samedirection. Alternatively, FIG. 4 illustrate how some embodiments includebeams 104 a, 104 b extending in generally opposite directions. Someembodiments may have more than two beams 104 and thus more than 2springs 106, anchoring arms 108, and scaffoldings 110.

In some embodiments, beams 104 a, 104 b may be the same length as shownin FIG. 4 or may have different lengths as depicted in FIG. 5 . Withdifferent length beams 104 a, 104 b, springs 106 a, 106 b reside atdifferent locations along the length of biopsy marker 100 and thusoccupy less space in a lateral/radial direction (i.e., perpendiculardirection with respect to longitudinal axis 112) than if springs 106 a,106 b occupied the same location along the longitudinal extent of biopsymarker 100. Ultimately, this reduction in space allows for the use of asmaller diameter delivery device 202.

Some embodiments, such as the ones depicted in FIGS. 6 and 7 , include asingle beam 104 extending between body section 102 and spring 106. Insome embodiments as depicted in FIG. 6 , beams 104 extend in a directiongenerally perpendicular to central longitudinal axis 114 of body section102. As depicted in FIG. 7 , some embodiments include beams 104extending in a direction generally parallel to central longitudinal axis114 of body section 102.

In some embodiments, as depicted in FIGS. 6 and 7 , spring(s) 106resides outside of bioabsorbable component 101 when bioabsorbablecomponent 101 is in a dehydrated state prior to and initially during theprocess of inserting biopsy marker 100 into a patient. Because spring(s)106 resides outside of bioabsorbable component 101 a when in adehydrated state, beam(s) 104 have a length greater than the distancebetween body section 102 and an outer surface, such as a longitudinalend, of bioabsorbable component 101 a when in the dehydrated state. Insome embodiments, beams 104 have a length sufficient to ensure thatscaffoldings 110 resides longitudinally beyond the longitudinal end ofbioabsorbable component 101 when in a hydrated state 101 b. In someembodiments, as depicted in FIG. 8 , beams 104 have a length greaterthan the distance between body section 102 and a longitudinal end ofbioabsorbable component 101 when in a hydrated state as identified byreference numeral 101 b.

The present invention further includes non-absorbable component 103having at least one spring-loaded anchor comprised of spring component106 (also referred to as “spring 106”), anchoring arm 108 andscaffolding 110. Springs 106 are located at the end of beam 104 oppositeof the end attached to or integrated with body section 102 of biopsymarker 100. Springs 106 allow their respective anchoring arms 108 toactively spring into an anchoring position to secure biopsy marker 100at the biopsy site.

At least spring 106 is comprised of a resilient material, such asnitinol, titanium, or stainless steel, so that biopsy marker 100 can beforced into an insertion configuration and can then rebound into ananchoring configuration when disposed within a patient's body. In someembodiments, spring component 106, anchoring arm 108 and scaffolding 110are comprised of one or more resilient materials. In other embodiments,the entire non-absorbable component 103 is comprised of resilientmaterial(s).

As provided in FIGS. 1-3 , springs 106 are depicted as torsion springs.The first end of each torsion spring is integrated with beam 104 and thesecond end of each torsion spring is integrated with anchoring arm 108.An embodiment of the spring component, however, may include activesprings of other designs known to a person of ordinary skill in the art,including but not limited to elbow springs, loop springs, leaf springs,helical springs, compression springs, plate springs, etc. Spring 106includes a position of repose in which the angle between the respectivebeam 104 and the respective anchoring arm 108 does not equal 180degrees.

As depicted in FIGS. 4-9 , spring 106 is an elbow spring. The elbowspring is easier to manufacture when non-bioabsorbable component 103 iscomprised of a single wire. Elbow spring 106 has a position of repose inwhich the angle between the respective beam 104 and the respectiveanchoring arm 108 does not equal 180 degrees. The elbow spring, however,may be bent out of its position of repose when subject to externalforces.

In an embodiment, spring 106 is designed so that the angle between beam104 and anchoring arm 108 is about 125 degrees when spring 106 is in aposition of repose. Some embodiments include spring 106 having aposition of repose in which the angle between beam 104 and anchoring arm108 is between 90 and 180 degrees. Some embodiments include spring 106having a position of repose in which the angle between beam 104 andanchoring arm 108 is between 100 and 160 degrees. Some embodimentsinclude spring 106 having a position of repose in which the angle beam104 and anchoring arm 108 is sufficient to ensure that scaffolding 110is outside of hydrogel in both the hydrated and dehydrated states.

In an embodiment, spring component 106 includes a structure that definesa hinge/rotational axis disposed between its respective beam 104 andanchoring arm 108. In other words, the spring capability is associatedwith structural components and features beyond simply bending aresilient member.

As previously explained, spring 106 allows non-bioabsorbable component103 to be manipulated into an insertion configuration. In the insertionconfiguration, anchoring arm 108 and in turn scaffolding 110 aremanipulated under a force greater than the spring force of spring 106.Anchoring arm 108 and in turn scaffolding 110 are forced towards centrallongitudinal axis 112 to reduce the cross-sectional area of biopsymarker 100 so that biopsy marker 100 fits within an internal lumen ofdelivery device 202 as depicted in FIG. 2A. Delivery device 202 can beany needle, catheter, or any other bio-insertable tubular structure thatcan be inserted into a patient to deliver biopsy marker 100 to a biopsysite. In some embodiments, spring 106 is adapted to permit anchoring arm108 and scaffolding 110 to be forced towards central longitudinal axis112 until non-absorbable component 103 has a cross-sectional area thatis equal to or smaller than the cross-sectional area of bioabsorbablecomponent 101.

When biopsy marker 100 is inserted into a patient, biopsy marker 100 isforced out of delivery device 202, using e.g. plunger device 204, andanchoring arm 108 and in turn scaffolding 110 spring into the anchoringconfiguration under the spring force from spring 106 when they exit theinternal lumen of delivery device 202 as depicted in FIG. 2B. In theanchoring configuration, the lateral/radial span, i.e. cross-sectionalarea, of biopsy marker 100 is greater than the cross-sectional area whenbiopsy marker 100 is in the insertion configuration. Typically, theanchoring arms 108 will spring outwardly away from central longitudinalaxis 112. Depending on the resiliency of the material of thenon-absorbable component 103 or the spring force of spring 106 and/orthe density of the surrounding tissue into which biopsy marker 100 isdeposited, the one or more anchoring arms 108 will return to theirrespective positions of repose or spring outwardly until the springforce of spring 106 equals the force of the tissue on the anchorassembly.

In some embodiments, springs 106 reside outside of bioabsorbablecomponent 101 when bioabsorbable component 101 is in a dehydrated state.In some embodiment, springs 106 reside outside of bioabsorbablecomponent 101 when bioabsorbable component 101 is in a hydrated state.In some embodiment, springs 106 reside outside of bioabsorbablecomponent 101 when bioabsorbable component 101 is in a dehydrated state,but not when bioabsorbable component 101 is in a hydrated state.

Anchoring arm(s) 108 extend further beyond spring(s) 106 in a directionaway from body section 102. Anchoring arms 108 are designed to engagetissue within a patient and project scaffolding(s) 110 further from bodysection 102 to engage tissue within a patient. Depending on theembodiment, biopsy marker 100 may have one or more anchoring arms 108.Typically, biopsy marker 100 will have one anchoring arm 108 for everyspring 106.

In some embodiments, anchoring arms 108 has a length greater than orequal to the distance (in the same direction of anchoring arm 108 whenin a position of repose) between spring 106 and an edge of bioabsorbablecomponent 101 when in a hydrated state. As a result, scaffolding 110engages a patient's tissue rather than bioabsorbable component 101. Insome embodiments having more than one anchoring arm 108, one anchoringarm has a length greater than the other so that scaffoldings 110 arelongitudinally spaced from each other and can thus occupy lesslateral/radial space when in the insertion orientation.

In some embodiments, anchoring arms 108 are a continuation of the singlewire of which other portions of nonabsorbable component 103 iscomprised. In some embodiments, anchoring arms 108 have the samecross-sectional size of portions of nonabsorbable component 103. In someembodiments, anchoring arms 108 have a larger cross-sectional size thanother portions of nonabsorbable component 103 to help anchoring arms 108engage the patient's tissue.

In some embodiments, anchoring arms 108 have a circular-shapedcross-section. In some embodiments, anchoring arms 108 have across-sectional shape that is not circular to increase friction with apatient's tissue and ultimately help anchoring arms 108 engage thepatient's tissue. In some embodiments, anchoring arms 108 have an outersurface with friction increasing elements or friction increasingmaterials to help anchoring arms 108 engage the patient's tissue.

The present invention further includes one or more scaffoldings 110 at adistal end of anchoring arms 108. Some embodiments include scaffoldings110 attached to or integrated with each anchoring arm 108. Scaffoldings110 provides another anchoring means and structural support for tissuegrowth post deployment. The tissue growth on and around scaffoldings 110helps to prevent biopsy marker 100 from migrating away from the biopsysite.

In an embodiment, each scaffolding 110 has a non-linear shape. In someembodiments, scaffoldings 110 have a loop shape, which is best seen inFIG. 4C. As depicted therein, distal most end 116 of scaffolding 110extends beyond anchoring arm 108 in forming the loop shape. Theextension of distal end 116 beyond anchoring arm 108 or the otherportions of scaffolding 110 ensure that distal end 116 is more capableof hooking into the patient's tissue. In addition, the loop shape isdesigned to leave hole 118 through which tissue can grow providingbetter purchase on scaffolding 110. Other embodiments may not includedistal most end 116 extending beyond anchoring arm 108 and/or may notinclude hole 118.

In some embodiments as depicted best in FIG. 1B, distal ends 116 of eachscaffolding 110 are looped inwards towards central longitudinal axes 112and 114. In some embodiments as depicted best in FIG. 4B, distal ends116 of each scaffolding 110 are looped outwards away from centrallongitudinal axes 112 and 114 in the same direction. In someembodiments, distal ends 116 of each scaffolding 110 are looped outwardsaway from central longitudinal axes 112 and 114 in opposite directions.In some embodiments as depicted best in FIG. 5 , distal ends 116 of eachscaffolding 110 are looped outwards away from central longitudinal axes112 and 114 and away from each other. The orientation of the loops andthe direction of distal ends 116 are optimized to reduce thelateral/radial space that scaffolding 110 occupy when in the insertionorientation. As a result, the internal lumen and thus delivery device202 as a whole can be reduced in cross-section to limit the size of theopening in a patient's body.

In some embodiments, includes scaffolding 110 having a barb-like shapeor a J-hook shape at distal end 116. The barb-like shape or a J-hookshape of distal end 116 is oriented in a way to prevent anchoring arm108 from moving back towards an insertion orientation or towards theinsertion site. In some embodiments, scaffolding 110 is any non-linearshape to prevent anchoring arm 108 from moving back towards an insertionorientation or towards the insertion site.

In some embodiments, scaffoldings 110 are a continuation of the singlewire of which other portions of nonabsorbable component 103 arecomprised. In some embodiments, scaffoldings 110 have the samecross-sectional size of portions of nonabsorbable component 103. In someembodiments, scaffoldings 110 have a larger cross-sectional size thanother portions of nonabsorbable component 103 to help scaffoldings 110engage the patient's tissue. In some embodiments, scaffoldings 110 havea circular-shaped cross-section. In some embodiments, scaffoldings 110have a cross-sectional shape that is not circular to increase frictionwith a patient's tissue and ultimately help scaffoldings 110 engage thepatient's tissue. In some embodiments, scaffoldings 110 have an outersurface with friction increasing elements or friction increasingmaterials to help scaffoldings 110 engage the patient's tissue.

During operation, biopsy marker 100 of the present invention has a sizeand shape that can be inserted into a patient using a bio-compatibledelivery device 202. Biopsy marker 100 is forced into the insertionorientation shown in FIG. 2A. In the insertion orientation, anchoringarms 108 are forced into a position in which the cross-sectional area ofbiopsy marker 100 is reduced to fit within the internal lumen ofdelivery device 202. This position includes anchoring arms 108 folded upand towards body section 102 in some embodiments (not shown) or down andaway from the body section 102 as shown in FIG. 2A to bring the anglebetween beams 104 and anchoring arms 108 to or near 180 degrees. Biopsymarker 100 is then forced into the inner lumen of delivery device 202and the inner lumen holds biopsy marker 100 in the insertionorientation.

Delivery device 202 is either already in position or is inserted intoposition at the biopsy site. The entry point into the biopsy site isthus generally the size of the cross-sectional area of the deliverydevice 202. Biopsy marker 100 can then be forced out of a distal end ofthe delivery device 202 and upon exiting delivery device 202, anchoringarms 108 actively spring outward into a position of repose (or as closeto a position of repose as a patient's tissue allows) and biopsy marker100 anchors itself into the tissue at the biopsy site. In the anchoringorientation, the span/cross-sectional area of biopsy marker 100 isgreater than the cross-sectional area of delivery device 202. As aresult, biopsy marker cannot exit the entry point into the biopsy sitewhen biopsy marker 100 is in the anchoring orientation. The activespring action into the anchoring orientation ensures that biopsy marker100 will remain at its insertion point.

In some embodiments, as best depicted in FIGS. 5, 6D-6F, and 7D-7F,bioabsorbable component 101 is an expandable material such as hydrogel.Bioabsorbable component 101 plays at least two roles. One role is to aidin imaging. By disposing biopsy marker 100 in hydrogel or anotherabsorbable substance, biopsy marker 100 is more easily visible duringultrasound scans after being embedded within a patient. Ultrasoundimaging shows air and water really well, so bioabsorbable component 101shows up as a black area in an ultrasound image. Because at least bodysection 102 is disposed within the hydrogel of bioabsorbable component101, the hydrogel surrounds body section 102 during a curing process tobind the components together. The metallic structure ofnon-bioabsorbable component 103 residing within bioabsorbable component101 shows up as air, in white, and provides an easily identifiablecontrast to locate biopsy marker 100. Imaging equipment is thereforeable to easily identify biopsy marker 100.

The other role of bioabsorbable component 101 is tied to its expandablenature. Prior to and during insertion, bioabsorbable component is in adehydrated state identifiable by reference numeral 101 a, as shown inFIGS. 6D-6F, and 7D-7F. The size/surface area of bioabsorbable component101 is smaller in the dehydrated stage as compared with the hydratedstage. Using an expandable bioabsorbable component 101 allows for thebiopsy marker to be reduced in size for insertion into a patient andexpand to fill holes or voids in patient tissue when deployed.

As depicted in FIGS. 7D and 7E, bioabsorbable component 101 may expandto twice the length and 2.67 times the diameter when hydrated. In someembodiments, bioabsorbable component 101 may expand between 1.5 and 3times in length. In some embodiments, bioabsorbable component 101 mayexpand between 1.5 and 3 times in diameter. In some embodiments,bioabsorbable component 101 expands in one direction. In someembodiments, bioabsorbable component 101 expands in two directions. Insome embodiments, bioabsorbable component 101 expands in all directions.

In an embodiment, non-bioabsorbable component 103 is comprised entirelyof a single wire construction. In an embodiment, non-bioabsorbablecomponent 103 is comprised of a single wire construction, wherein thewire has a generally circular cross-section. Starting with a singlewire, body section 102, beams 104, spring components 106, anchoring arms108, and scaffoldings 110 can be constructed by bending the wire intothe desired anchoring orientation. Using a single wire constructiongreatly reduces the manufacturing time, costs, and complexities.

In some embodiments, biopsy marker 100 has a total length in thelongitudinal direction between about 1 mm and 20 mm when in a dehydratedstate. In some embodiments, the length of biopsy marker 100 is between7.5 mm and 10 mm when dehydrated. In some embodiments, biopsy marker 100has a length of 5 mm when dehydrated and an outer diameter of 1.3 mmwhen dehydrated. In some embodiments, non-bioabsorbable component 103has a total length in the longitudinal direction between about 1 mm and7 mm.

The advantages set forth above, and those made apparent from theforegoing description, are efficiently attained. Since certain changesmay be made in the above construction without departing from the scopeof the invention, it is intended that all matters contained in theforegoing description or shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended tocover all the generic and specific features of the invention hereindescribed, and all statements of the scope of the invention that, as amatter of language, might be said to fall therebetween.

What is claimed is:
 1. A biopsy marker, comprising: a bioabsorbablecomponent; a non-bioabsorbable component, the non-bioabsorbablecomponent including: a body section having a predefined non-linearshape, wherein the body section resides at least partially within thebioabsorbable component; a first beam extending from the body section toa first spring component; the first spring component residing between afirst anchoring arm and the first beam; an insertion orientation and ananchoring orientation, the insertion orientation including the biopsymarker having a lateral span that is less than the lateral span of thebiopsy marker when in the anchoring orientation; the insertionorientation including the first anchoring arm subject to an externalforce to overcome a spring force from the first spring component; andthe anchoring orientation including the first anchoring arm being freeof the external force and the first spring component causing the firstanchoring arm to spring outward to increase the lateral span of thebiopsy marker.
 2. The biopsy marker of claim 1, further including anon-linear scaffolding section at a distal end of the first anchoringarm.
 3. The biopsy marker of claim 2, wherein the scaffolding sectionincludes a j-hook or a barb-like feature.
 4. The biopsy marker of claim1, wherein the body section has a coil-shape.
 5. The biopsy marker ofclaim 1, wherein the first spring component is a torsion spring.
 6. Thebiopsy marker of claim 1, wherein the first spring component is an elbowspring.
 7. The biopsy marker of claim 1, wherein the non-bioabsorbablecomponent is made from a metallic material.
 8. The biopsy marker ofclaim 1, wherein the non-bioabsorbable component is comprised of asingle continuous wire.
 9. The biopsy marker of claim 1, furtherincluding the bioabsorbable component comprised of an expandablematerial that can be dehydrated to reduce its size and hydrated toincrease its size.
 10. The biopsy marker of claim 9, further including:the body section residing within the bioabsorbable component when thebioabsorbable component is in a dehydrated state; the first beam havinga length greater than a distance between the body section and an outersurface of the bioabsorbable component when in the dehydrated state,such that the first spring component resides outside of thebioabsorbable component when in the dehydrated state.
 11. The biopsymarker of claim 1, further including: a second beam extending from thebody section to a second spring component; the second spring componentresiding between a second anchoring arm and the second beam; theinsertion orientation further including the second anchoring arm beingsubject to a force to overcome the spring force from the second springcomponent; and the anchoring orientation further including the secondanchoring arm being free of the force and the second spring componentcausing the second anchoring arm to spring outward to increase thelateral span area of the biopsy marker.
 12. A biopsy marker, comprising:a bioabsorbable component, wherein the bioabsorbable component can bedehydrated to reduce its size and hydrated to increase its size; anon-bioabsorbable component comprised of a single wire, thenon-bioabsorbable component including: a body section having apredefined non-linear shape, wherein the body section resides at leastpartially within the bioabsorbable component; a first beam extendingfrom the body section to a first spring component; the first springcomponent residing between a first anchoring arm and the first beam; aninsertion orientation and an anchoring orientation, the insertionorientation including the biopsy marker having a lateral span that isless than the lateral span of the biopsy marker when in the anchoringorientation; the insertion orientation including the first anchoring armsubject to an external force to overcome a spring force from the firstspring component; and the anchoring orientation including the firstanchoring arm being free of the external force and the first springcomponent causing the first anchoring arm to spring outward to increasethe lateral span of the biopsy marker.
 13. The biopsy marker of claim12, further including a non-linear scaffolding section at a distal endof the first anchoring arm.
 14. The biopsy marker of claim 12, whereinthe body section has a coil-shape.
 15. The biopsy marker of claim 12,wherein the first spring component is a torsion spring.
 16. The biopsymarker of claim 12, wherein the first spring component is an elbowspring.
 17. The biopsy marker of claim 12, further including: the bodysection residing within the bioabsorbable component when thebioabsorbable component is in a dehydrated state; the first beam havinga length greater than a distance between the body section and an outersurface of the bioabsorbable component when in the dehydrated state,such that the first spring component resides outside of thebioabsorbable component when in the dehydrated state.
 18. The biopsymarker of claim 12, further including: a second spring componentresiding between a second anchoring arm and the body section; theinsertion orientation further including the second anchoring arm beingsubject to an external force to overcome the spring force from thesecond spring component; and the anchoring orientation further includingthe second anchoring arm being free of the external force and the secondspring component causing the second anchoring arm to spring outward toincrease the lateral span area of the biopsy marker.
 19. Anon-bioabsorbable component of a biopsy marker, comprising: a bodysection having a predefined non-linear shape; a first beam extendingfrom the body section to a first spring component; the first springcomponent residing between a first anchoring arm and the first beam; asecond beam extending from the body section to a second springcomponent; the second spring component residing between a secondanchoring arm and the second beam; an insertion orientation and ananchoring orientation, the insertion orientation including the biopsymarker having a lateral span that is less than the lateral span of thebiopsy marker when in the anchoring orientation; the insertionorientation including the first anchoring arm subject to an externalforce to overcome a spring force from the first spring component and thesecond anchoring arm subject to the external force to overcome a springforce from the second spring component; and the anchoring orientationincluding the first and second anchoring arms being free of the externalforce and the first and second spring components respectively causingthe first and second anchoring arm to spring outward to increase thelateral span of the biopsy marker.
 20. The biopsy marker of claim 19,further including: a bioabsorbable component, wherein the bioabsorbablecomponent can be dehydrated to reduce its size and hydrated to increaseits size; the body section residing within the bioabsorbable componentwhen the bioabsorbable component is in a dehydrated state; the firstbeam having a length greater than a distance between the body sectionand an outer surface of the bioabsorbable component when in thedehydrated state, such that the first spring component resides outsideof the bioabsorbable component when in the dehydrated state; and thesecond beam having a length greater than a distance between the bodysection and an outer surface of the bioabsorbable component when in thedehydrated state, such that the second spring component resides outsideof the bioabsorbable component when in the dehydrated state.